MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number	305706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iv being removed from patient discharge, upon removal the rn notice the catheter was missing.Ultrasound completed and found 3/4 of the 1" catheter in the cephalic vein.Md performed procedure at bedside to cut catheter from the vein.
Additional Manufacturer Narrative
Other, other text: there were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.

• Brand Name: JELCO PROTECTIV SAFETY IV CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14621324
• Report Number: 3012307300-2022-10939
• Device Sequence Number: 4456207
• Product Code: FOZ
• UDI-Device Identifier: 10351688071149
• UDI-Public: 10351688071149
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2024
• Device Model Number: 305706
• Device Catalogue Number: 305706
• Device Lot Number: 4237288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown